Actively Recruiting
Effects of Intermittent Fasting and Its Combination with High-Intensity Interval Training on Inflammatory and Metabolic Markers, As Well As the Microbiome in Patients with Metabolic Syndrome: a Randomized Controlled Pilot Study
Led by University of Erlangen-Nürnberg Medical School · Updated on 2025-03-20
250
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of intermittent fasting, alone and combined with high-intensity interval training, on inflammation and metabolism in adults with obesity and metabolic syndrome. This randomized controlled pilot study aims to find out if these interventions reduce chronic inflammation, measured by hsCRP, in patients with metabolic syndrome compared to healthy controls. The study is sponsored by the University of Erlangen-Nürnberg Medical School and includes adults aged 18 to 80 years. Participants are divided into five groups: three intervention groups with metabolic syndrome who follow either alternate-day fasting, time-restricted eating, or time-restricted eating plus high-intensity interval training, all alongside regular Mediterranean diet advice. Two control groups include metabolic syndrome patients and healthy individuals both receiving only Mediterranean diet advice. The intervention lasts 3 months, followed by a 3-month follow-up phase. During the 6-month study, participants attend six in-person visits and two phone visits for assessments and nutritional counseling. Researchers will measure inflammatory and metabolic markers, body composition, blood pressure, liver fat, and the composition of intestinal, oral, and skin microbiomes. The main outcome is the change in hsCRP from enrollment to the end of the 3-month intervention. Safety and adherence are monitored throughout the study.
CONDITIONS
Brief Title
Effects of Intermittent Fasting and Exercise on Inflammation, Metabolism, and the Microbiome in Metabolic Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written consent to participate in the study.
- Persons aged 18 years and older.
- Diagnosis of Metabolic Syndrome (MetS) with elevated hsCRP.
You will not qualify if you...
- Pregnant or nursing individuals.
- Cardiovascular diseases or orthopedic restrictions that prevent exercise.
- Use of medication or supplements that significantly affect study outcomes (e.g., anti-inflammatory medications, antibiotics within the last 6 weeks).
- Body weight greater than 200 kg (maximum capacity of training equipment).
- Individuals with mental illnesses that may impair their ability to understand or participate in the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants follow assigned interventions including alternate day fasting, time restricted eating, or time restricted eating combined with high-intensity interval training, along with regular advice on the Mediterranean diet, or serve as controls with diet advice only.
Trial Site Locations
Total: 1 location
1
Hector-Center for Nutrition, Exercise and Sports, University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
Research Team
P
Prof. Dr. med. Yurdagül Zopf
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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